ICU Medical recalls
7 recent recalls on record for ICU Medical in connected official government data as of September 7, 2026 at 6:00 AM UTC.
Models with recalls
All ICU Medical recalls
FDA Class II · Medical device · July 29, 2026
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing t…
Official ID Z-2759-2026 ·
Official record ↗
FDA Class II · Medical device · July 22, 2026
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Official ID Z-2724-2026 ·
Official record ↗
FDA Class II · Medical device · July 22, 2026
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Official ID Z-2723-2026 ·
Official record ↗
FDA Class II · Medical device · June 17, 2026
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may…
Official ID Z-2313-2026 ·
Official record ↗
FDA Class II · Medical device · June 17, 2026
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may…
Official ID Z-2312-2026 ·
Official record ↗
FDA Class II · Medical device · June 17, 2026
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may…
Official ID Z-2311-2026 ·
Official record ↗
FDA Class II · Medical device · May 27, 2026
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy …
Official ID Z-2210-2026 ·
Official record ↗
Compiled from official public-domain government data. Last checked September 7, 2026 at 6:00 AM UTC.